A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published studies, this study hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Bipolar Depression

NCT00186485

Bipolar Disorder

COMPLETED NA

rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II

NCT00447096

Bipolar Disorder

WITHDRAWN PHASE2

Transcranial Magnetic Stimulation for Bipolar Depression

NCT00470639

Bipolar Depression

WITHDRAWN PHASE1/PHASE2

Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression

NCT01566591

Bipolar Depression

UNKNOWN NA

Efficacy of rTMS in Bipolar Depression

NCT02749006

Bipolar Depression

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Candidate with bipolar depression will be screened after signing informed consent. Those who meet the selection criteria will be treated with daily rTMS for 3 weeks and be followed-up at 2 weeks. Participants will keep their ongoing medication unless a medication significantly increases the possibility of seizure. They must be on the same dose of antidepressant medication for least 4 weeks without improvement of symptoms before being recruited into the study. Mood and other observed mental status will be measured by standard psychological scales.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mood Disorder Bipolar Disorder Major Depression Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

rTMS treatment

Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim

Group Type EXPERIMENTAL

Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.

Intervention Type DEVICE

High frequency repetitive TMS given daily on weekdays for 3 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.

High frequency repetitive TMS given daily on weekdays for 3 weeks

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Repetitive Transcranial Magnetic Stimulation (rTMS)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* bipolar I or II patients, currently in a depression episode
* Patient must have failed at least 2 medication
* Score of 21-item Hamilton Rating Scale for Depression (HAM-D)

Exclusion Criteria

* Rapid cycling bipolar or mixed episode of mood disorder by definition of current DSM criteria
* Substantial risk of suicide during the screening period that requires inpatient care
* Presence of psychosis
* Dual diagnosis of other primary, currently clinically significant severe mental disorders
* History of other significant neurological diseases, such as seizure disorder, stroke, brain tumors, abnormalities in the blood vessels in brain, dementia, Parkinson's disease, Huntington's chorea or multiple sclerosis
* History of any medical event that may increase the risk of having seizure, such as head trauma with unconsciousness for more than 5 minutes or a family history of seizure
* Significant medical complications that may deteriorate during the trial or have increased likelihood of danger consequences
* Patients who are pregnant or intend to become pregnant during the study period
* Any metallic prosthesis in head, neck or upper body (including cardiac pace maker) that cannot be safely removed during treatment
* Current Vagus Nerve Stimulation (VNS) treatment or Electroconvulsive Therapy (ECT) treatment, or with history of failed ECT treatment
* Patient's Motor Threshold for TMS cannot be detected
* Significant side effects which are intolerable during the screening or any later stage of the trial
* Started psychotherapy within the previous 8 weeks or foreseeable psychotherapy will be started or changed in 6 weeks

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No